The present invention relates to an apparatus and method for the cleansing and antisepsis of the vagina.
Currently available means, not requiring a physician, for the treatment of vaginal irritation, itching or infections, and also for regular vaginal hygiene include douching with fluids and inserting suppositories, gels, creams, or ointments into the vagina, either by hand or by vaginal applicators.
Douching is conducted either by utilizing a standard reusable vaginal douche apparatus, which consists of a bag and hook and a long tube and clamp, or by utilizing a single-use, disposable douche consisting of a plastic bottle with a long nozzle.
The technique of douching involves causing a fluid (such as water, pH adjusted water, or water mixed with antiseptics, etc.) to flow in and out of the vagina either by the force of gravity or by pressure. In douching, it is hoped that the fluid will remove unwanted substances such as secretions, bacteria, or yeast, that some of the fluid will remain inside the vagina to achieve a desirable effect such as deodorizing or refreshing, and that certain amounts of the fluid will come into contact with the appropriate areas of the vagina for an effective length of time. The latter is most important in cases where medicated douches are used for treatment of vaginal infections or overgrowth of germs such as yeast, bacteria, molds, chlamydia or viruses. In many cases where a medicated douche is used, not only does the solution have to come into contact with the infected or affected area, but it also must remain in contact with such area for a sufficient period of time to produce the desired results.
Douching with the standard reusable technique utilizing a douche bag and tube is cumbersome because, for douching to be most effective, the user has to lie on a flat surface such as a bathtub or an appropriately covered bed with the pelvis elevated and the bag at an appropriate elevation, and must insert the tube as deeply as possible into the vagina. In utilizing a medicated solution, it is hoped that the solution will, by the force of gravity, reach all of the infected areas and remain in contact with such areas for a sufficient period of time to exert a germicidal effect.
While douching may be an acceptable means for rinsing or deodorizing the vagina, it is not an efficient and effective technique to disinfect the vagina, particularly when medicated solutions are used. This is due to the position of the vaginal canal, its shape and depth, the downward direction of its outer opening, and, in particular, its inner topographic anatomy and physiology. Specifically, difficulties arise because the inner end of the vagina is ring-shaped, with the vaginal dome collapsing against the uterine cervix (anterior and posterior fornix). In addition, the vaginal walls are normally collapsed against each other; and the inner surfaces of the vaginal walls have multiple rugae, villi, folds and creases. In order for douching to be an effective technique, all of these areas have to be stretched adequately for a period of time sufficient to allow the douching fluid to come into contact with them. This becomes even more crucial when medicated solutions are used since the medication not only has to come into contact with the surface where the bacteria or yeast are attached or anchored, but also has to remain there for a sufficient period of time, surviving vaginal secretions, to exert the desired effect.
Utilizing disposable-type douches wherein a nozzle is used to force fluid into the vagina may be less cumbersome, but still suffers from the same disadvantages as those of the standard douching technique. In addition, although the disposable douche technique may produce a more forceful flow of fluid, the flow is limited to the outer part of the vagina because of the size of the nozzle. The nozzle in most cases is not long enough to reach the proximal part of the vagina, i.e., the section towards the cervix. As in standard douches, the fluid reaches the inner part of the vagina only by passive flow, which is inadequate to enable all parts of the vagina to be contacted, particularly at the paracervical dome. Also, the amount of fluid in one disposable douche may not be adequate to distend the vaginal walls and to maintain them in a distended position for a long enough time to expose the vaginal creases and folds to an adequate amount of the medicated fluid. In addition, there is the possibility that the hard nozzle of the disposable douche may cause injury to the vagina.
Because of the above mentioned shortcomings of douching methods, particularly in providing adequate means of hygiene in the proximal part of the vagina and the vulvar area, it is necessary that other antiseptic methods be employed.
Another known method of providing local vaginal hygiene involves the use of vaginal inserts such as tablets, caplets, ointments, creams or gels. These can be inserted into the vagina either by hand or by an applicator. In using such inserts, it is hoped that the inserts eventually will become dispersed and reach all of the affected areas of the inner vagina by melting or mixing with vaginal secretions. These inserts must be delivered by insertion as far as possible into the vaginal tract. Because the tablets are usually too small and the vaginal applicators cannot deliver a large enough dose of medication, it may be necessary to use several doses in an attempt to reach all of the affected areas of the vaginal canal. In addition, in order for the inserts to be most effective, the user has to remain in a horizontal position for a prolonged period of time. Otherwise, a significant portion of the medicated substance will be discharged along with vaginal secretions, particularly when inflamation is present.
Vaginal inserts suffer from the additional disadvantage that residual material such as binders, excipients, etc. and also medication can remain in the vagina and lose their effectiveness after a period of time. This can be caused by body heat, vaginal secretions or pH. Therefore, to achieve vaginal cleansing, the user is often forced to utilize additional douching techniques to remove the remaining materials from the vagina. In the case of gels and ointments that are not water soluble, the residue is often left behind even after douching.
Vaginal inserts also suffer from the same disadvantage as douching techniques in that the shape and configuration of the vagina limits the amount of contact of medication with certain areas of the vagina, particularly at the paracervical dome and the areas covered by downward oriented rugae.